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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT DYONICS 25 ARTHROSCOPE
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SMITH & NEPHEW, INC. CONTROL UNIT DYONICS 25 ARTHROSCOPE Back to Search Results
Catalog Number 7211010
Device Problems Pressure Problem (3012); Insufficient Information (3190)
Patient Problem Inflammation (1932)
Event Date 10/01/2019
Event Type  malfunction  
Event Description
It was reported that during a shoulder surgery, the pump was not working correctly. It was unable to maintain a flow rate or pressure. The device stopped to work throughout the case for prolonged periods, having a difficultly visualization and need for use of flush function several times. An extra 60-90 minutes were added to the case resulting in extra time of the patient under anesthesia. It resulted in greater than normal swelling in the shoulder as well. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameCONTROL UNIT DYONICS 25
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9406048
MDR Text Key169130344
Report Number1643264-2019-00853
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171794
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7211010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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